Seralutinib (GB002) Clinical Trials

Size	Price	Qty
5mg	USD 369
25mg	USD 1,107

Clinical Trials

Multiple clinical trials evaluate seralutinib (GB002), an inhaled kinase inhibitor targeting pulmonary vascular remodeling, across Phase 1 through Phase 3 studies. These trials focus on pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, and safety profiling in healthy subjects, with statuses encompassing completed studies, active or recruiting Phase 3 trials, and suspended protocols. Industry sponsors supporting this research include Gossamer Bio Inc., Pulmokine Inc., Worldwide Clinical Trials, and Zhejiang Echon Biopharm Limited.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07181382	SUSPENDED	Pulmonary Hypertension Associated With Interstitial Lung Disease	GB002, Inc.	2026-02	PHASE3
NCT04816604	ACTIVE_NOT_RECRUITING	Pulmonary Arterial Hypertension	Gossamer Bio USA, Inc.	2021-04-05	PHASE2
NCT06274801	RECRUITING	Pulmonary Arterial Hypertension	Gossamer Bio USA, Inc.	2024-09-03	PHASE3
NCT06423261	ACTIVE_NOT_RECRUITING	Healthy	Zhejiang Echon Biopharm Limited	2023-08-24	PHASE1
NCT05934526	COMPLETED	Pulmonary Arterial Hypertension	GB002, Inc.	2023-12-28	PHASE3
NCT04456998	COMPLETED	Pulmonary Artery Hypertension	GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.	2020-11-12	PHASE2
NCT03926793	COMPLETED	Pulmonary Arterial Hypertension	GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.	2020-02-04	PHASE1
NCT03926793	Completed	Pulmonary Arterial Hypertension	GB002 Inc. a wholly owned subsidiary of Gossamer Bio Inc.\|Gossamer Bio Inc.	2020-02-04	Phase 1
NCT03473236	COMPLETED	Safety Issues	GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.	2017-09-06	PHASE1
NCT03473236	Completed	Safety Issues	GB002 Inc. a wholly owned subsidiary of Gossamer Bio Inc.\|Pulmokine Inc.\|Worldwide Clinical Trials\|Gossamer Bio Inc.	2017-09-06	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-03-19)

Check the Seralutinib (GB002) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Seralutinib selectively binds to and inhibits platelet-derived growth factor receptors alpha and beta (PDGFRα and PDGFRβ), suppressing downstream receptor autophosphorylation and intracellular signal transduction. By halting aberrant pulmonary artery smooth muscle cell proliferation and vascular remodeling, this inhibition aims to reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).